Tongue stabilizing device

ABSTRACT

A one piece tongue stabilizing device formed of a resiliently flexible material and comprises a body having a hollow interior within which the end of a user&#39;s tongue fits and is held by negative pressure. The body of the device comprises an entry portion having an opening to the hollow interior of the device and a bulb portion connected by a narrower diameter neck portion. Tabs extend from the bulb portion which in use engage the exterior of the user&#39;s face around the user&#39;s mouth or between the user&#39;s teeth and lips, to hold the tongue forward to assist in opening user&#39;s airway and reducing snoring. A major benefit of the device of the invention is that it does not require specialist fitting or the taking of upper and lower jaw impressions of the patient to produce a tailored device for the patient.

FIELD

The invention comprises a tongue stabilising device for use in reducingsnoring.

BACKGROUND

Sleep disorders are very common. It has been reported that each yeararound 50 million report trouble with sleeping and 10 million of themseek medical attention. Inadequate sleep can lead to daytime sleepinessand other sleep related problems.

One form of sleep disorder is sleep apnoea, which is defined as acessation of airflow greater than or equal to 10 seconds 5 times perhour of sleep time. One form of apnoea is obstructive apnoea which is anabsence of airflow due to airway obstruction in the upper airway.

Snoring is created by the vibration of the pharyngeal soft tissues asair passes through an airway that is too small to allow for smooth,unimpeded flow. While obstructive apnoea is marked by total airwayclosure, snoring is a symptom of partial closure or near collapse.Snoring indicates a partial airway obstruction. That is, as the airflows through a partial obstruction, vibration of tissue occurs,creating the sound of snoring. Many times snoring is a warning sign ofimpending apnoea. Though some snoring is truly benign and merelyobnoxious noise, it has been shown that some instances of loud, regularsnoring are associated with true medical morbidity even in the absenceof overt obstructive apnoea. Due to the exaggerated breathing effort andnoise created by the high resistance to airflow in the upper airway andconsequential repetitive arousals from sleep, these heavy snorers mayexhibit symptoms common to actual obstructive sleep apnoea. The hallmarkof obstructive sleep apnoea is snoring, which is intermittent.

Oral appliance therapy is becoming increasingly popular to treatselected cases of sleep disordered breathing. ¹While not completelyeffective in all situations, research is showing that oral appliancesare very effective in treating snoring in mild obstructive sleep apnoea.¹ In a preferred form the hollow interior of the device has a generalheart shape in cross-section at said neck portion.

U.S. Pat. No. 5,465,734 to Snorex, Inc discloses a tongue retainingdevice which is typically formed of a flexible polyvinyl material andcomprises a hollow interior which fits over the forward end of thetongue and with which the tongue is held forward by negative pressurecreated with the device. The device has a particular shape, isadjustable in relation to engagement with the users face, and requiresspecialist fitting or the taking of upper and lower jaw impressions ofthe patient to produce a tailored device for the patient.

SUMMARY OF INVENTION

The present invention provides an improved, or at least alternative,form of oral therapy appliance useful for eliminating or reducingsnoring.

In broad terms the invention comprises a one piece tongue stabilisingdevice formed of a resiliently flexible material and comprising a bodyhaving a hollow interior within which the end of a user's tongue fitsand is held by negative pressure when the device is fitted on to theuser's tongue and which body comprises an entry portion having anopening to the hollow interior of the device and a bulb portionconnected by a narrower diameter neck portion, and tabs extending fromthe bulb portion which in use engage the exterior of the user's facearound the user's mouth or between the user's teeth and lips, to holdthe tongue forward to assist in opening user's airway and reducingsnoring.

Preferably the entry portion is tapered with a reducing diameter fromsaid opening to said neck portion.

Preferably at least the opening and entry portion have a largercross-sectional dimension across the device.

A major benefit of the device of the invention is that it does notrequire specialist fitting or the taking of upper and lower jawimpressions of the patient to produce a tailored device for the patient.Rather it is possible to sell the device in a range of a few sizes, overthe counter and without requiring special fitting. This is a majoradvance in terms of cost reduction and ensuring wide spread availabilityto assist persons with sleep apnoea. This is due to the shape of thedevice.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings show a preferred form of tongue stabilisingdevice of the invention, by way of example and without intending to belimiting. In the drawings:

FIG. 1 is a side view of the device,

FIG. 2 is a front view of the device in the direction of arrow A in FIG.1,

FIG. 3 is a view of the device from below in the direction of arrow B inFIG. 1,

FIG. 4 shows the cross-sectional shape of the device across the neckportion of the device, and

FIG. 5 shows the device in use.

DETAILED DESCRIPTION OF PREFERRED FORM

The preferred form of tongue stabilising device comprises a body shapedas shown and also having a hollow interior. The device is formed from aresiliently flexible material and typically a synthetic material such asa polyvinyl material or similar.

The body of the device comprises a hollow bulb portion 2 and an entryportion 3, which are connected by a narrower diameter neck portion 4.The entry portion 3 has an opening into the hollow interior and istapered with a reducing diameter from the opening to the neck portion 4,so that the neck portion 4 has the narrowest diameter across the device.In the preferred form the shape of the device is such that at least theentry portion and the neck portion are wider across the device than theyare in a vertical direction (in orientation of the device during normaluse) and the bulb portion 2 may also have a similar shape, but this maynot be essential.

In addition in the preferred form the hollow interior of the device hasa heart shape in cross-section at the neck portion, as shown in FIG. 4.Preferably a cut out 7 is formed in the device as shown in FIG. 3 toaccommodate the web beneath the user's tongue.

Locating tabs 8 and 9 extend from the top and bottom of the bulb 2. Thedevice is a unitary device with the locating tabs 8 and 9 integrallymoulded with the body of the device. Preferably but not essentially thetabs 8 and 9 are also hollow (communicating with the hollow interior ofthe device and particularly the bulb portion 2), to increase the volumewithin the device for maximising negative pressure to retain the deviceon a user's tongue.

In use, the bulb end of the bulb portion 2 of the device is squeezedsomewhat and the device is pushed over the end of the user's tongue bythe user. The bulb is then released so that it will return to itsoriginal shape applying negative pressure within the device to the endof the user's tongue so that the device will be retained on the end ofthe tongue. In use, the tabs 8 and 9 will then engage the exterior ofthe user's face, with the upper tab 8 resting against the user's upperlip and the lower tab 9 which is preferably slightly longer as shownresting against the user's lower lip and chin area. Alternatively thetabs 8 and 9 may be positioned slightly further back on the bulb portionfrom the front end of the bulb portion so that they are positioned tofit between the teeth and lips of the user, and will engage against theuser's teeth.

The tongue stabilising device of the invention fits against the mouth orteeth of the user as shown. It may be provided in a number of sizes butbecause of its shape does not need to be specially fitted or require thetaking of upper and lower jaw impressions as with conventional tongueretaining devices. It can therefore be retailed “over the counter” atchemists or pharmacies for example. The device can also be used withedentulous patients.

The foregoing describes the invention including a preferred formthereof. Alterations and modifications as will be obvious to thoseskilled in the art are incorporated within the scope hereof as definedin the following claims.

1. A one piece tongue stabilising device formed of a resilientlyflexible material and comprising a body having a hollow interior withinwhich the end of a user's tongue fits and is held by negative pressurewhen the device is fitted on to the user's tongue and which bodycomprises an entry portion having an opening to the hollow interior ofthe device and a squeezable expanded bulb portion connected by anarrower diameter neck portion, and having a flexible wall sectionwhereby the expanded bulb portion may be squeezed and released inapplication of the device to a user's tongue, the length dimension ofthe device from the opening to said entry portion to the narrowest partof said neck portion being shorter than the length dimension of thedevice from the narrowest part of said neck portion to the distal end ofsaid bulb portion, said body also comprising a cut out into the sidewall of the entry portion, and integrally moulded tabs extending fromthe bulb portion which in use engage the exterior of the user's face orbetween the user's teeth and lips, to hold the tongue forward to assistin opening user's airway and reducing snoring, said tabs comprising afirst tab extending from the exterior of said expanded bulb portionsubstantially perpendicular to a longitudinal axis of the device.
 2. Atongue stabilising device according to claim 1 wherein said entryportion is tapered with a reducing diameter from said opening to saidneck portion.
 3. A tongue stabilising device according to claim 2wherein at least said opening and said entry portion have a largercross-sectional dimension across the device.
 4. A tongue stabilisingdevice according to claim 2 wherein the hollow interior of the devicehas a general heart shape in cross-section at said neck portion.
 5. Aone piece tongue stabilising device formed of a resiliently flexiblematerial and comprising a body having a hollow interior within which theend of a user's tongue fits and is held by negative pressure when thedevice is fitted on to the user's tongue and which body comprises anopening to the hollow interior of the device, a squeezable expanded bulbportion, and a narrower diameter neck portion between said opening andsaid bulb portion and which is tapered with a reducing diameter fromsaid opening to said neck portion and having a flexible wall sectionwhereby the bulb portion may be squeezed and released in application ofthe device to a user's tongue to create said negative pressure whichretains the device on the user's tongue, the length dimension of thedevice from the opening to said entry portion to the narrowest part ofsaid neck portion being shorter than the length dimension of the devicefrom the narrowest part of said neck portion to the distal end of saidbulb portion, and integrally moulded tabs extending from the bulbportion which in use engage the exterior of the user's face, said tabscomprising a first tab extending from the exterior of said bulb portionsubstantially perpendicular to a longitudinal axis of the device and asecond tab extending in substantially an opposition direction to saidfirst tab, one or both of said tabs having a hollow interior whichcommunicates with the interior of the expanded bulb portion, said tabsbeing shaped and positioned to contact a centre region of a user's upperand lower lips but not over the user's lips in the corner regions of themouth on either side, to hold the tongue forward to assist in openingthe user's airway and reducing snoring.
 6. A tongue stabilising deviceaccording to claim 1 wherein one or both of said tabs have hollowinterior which communicates with the interior of the expanded bulbportion.
 7. A one piece tongue stabilising device formed of aresiliently flexible material and comprising of a body having a hollowinterior within which the end user's tongue fits and is held by negativepressure when the device is fitted on to the user's tongue and whichbody comprises an entry portion having an opening to the hollow interiorof the device and a squeezable expanded bulb portion connected by anarrower diameter neck portion; and having a flexible wall sectionwhereby the expanded bulb portion may be squeezed and released inapplication of the device to a user's tongue to create said negativepressure which retains the device on the user's tongue, the lengthdimension of the device from the opening to said entry portion to thenarrowest part of said neck portion being shorter than the lengthdimension of the device from the narrowest part of said portion to thedistal end of said bulb portion, and integrally moulded tabs extendingfrom the bulb portion which in use engage the exterior of the user'sface or between the user's teeth and lips, to hold the tongue forward toassist in opening the user's airway and reducing snoring, one or both ofsaid tabs having a hollow interior which communicates with the interiorof the expanded bulb portion, said tabs comprising a first tab extendingfrom the exterior of said expanded bulb portion substantiallyperpendicular to a longitudinal axis of the device and a second tabextending in substantially an opposite direction to said first tab, saidtabs being shaped and positioned to contact the user's lips or betweenthe user's teeth and lips in a centre region of a user's upper and lowerlips but not over the user's lips or between the user's lips and mouthin the corner regions of the mouth on either side.
 8. A tonguestabilising device according to claim 5 wherein at least said openingand said entry portion have a larger cross-sectional dimension acrossthe device.
 9. A tongue stabilising device according to claim 8 whereinthe hollow interior of the device has a general heart shape incross-section at said neck portion.
 10. A tongue stabilising device andcomprising a body having a hollow interior within which the end of auser's tongue fits and is held by negative pressure when the device isfitted on to the user's tongue and which body comprises an entry portionhaving an opening to the hollow interior of the device and a squeezableexpanded bulb portion having a flexible wall section whereby theexpanded bulb portion may be squeezed and released in application of thedevice to a user's tongue to create said negative pressure which retainsthe device on the user's tongue, the device having a part which engagesthe user's face to hold the tongue forward to assist in opening theuser's airway and reducing snoring wherein said part comprises a firsttab extending from the exterior of said expanded bulb portionsubstantially perpendicular to a longitudinal axis of the device and asecond tab extending in substantially an opposite direction to saidfirst tab, the device being a one piece device moulded from aresiliently flexible material with said tabs being integrally mouldedwith said bulb portion and shaped and positioned to contact the user'slips or between the user's teeth and lips in a centre region of a user'supper and lower lips but not over the user's lips or between the user'slips and mouth in the corner regions of the mouth on either side, andwherein said entry portion is connected to said expanded bulb portion bya narrower diameter neck portion with said entry portion being taperedwith a reducing diameter from said opening to said neck portion, saidopening and said entry portion being resiliently flexible and having alarger cross-sectional dimension across the device, the hollow interiorof the device having a general heart shape in cross-section at said neckportion.
 11. A tongue stabilising device according to claim 5 whereinone of said tabs extends from a point on the exterior of said bulbportion closer to said entry portion than the other of said tabs.
 12. Atongue stabilising device according to claim 11 wherein said one of saidtabs is longer than the other of said tabs.
 13. A tongue stabilisingdevice as claimed in claim 10 including a cut-out into the side wall ofthe entry portion.
 14. A tongue stabilising device according to claim 7wherein said entry portion is tapered with a reducing diameter from saidopening to said neck portion.
 15. A tongue stabilising device accordingto claim 7 wherein at least said opening and said entry portion have alarger cross-sectional dimension across the device.
 16. A tonguestabilising device according to claim 7 wherein the hollow interior ofthe device has a general heart shape in cross-section at said neckportion.
 17. A tongue stabilsing device as claimed in claim 16 includinga cut out into the side wall of the entry portion.
 18. A tonguestabilising device according to claim 13 wherein one or both of saidtabs have a hollow interior which communicates with the interior of theexpanded bulb portion.
 19. A tongue stabilising device according toclaim 18 wherein one of said tabs extends from a point on the exteriorof said bulb portion closer to said entry portion than the other of saidtabs.
 20. A tongue stabilising device according to claim 19 wherein saidone of said tabs is longer than the other of said tabs.
 21. A tonguestabilising device according to claim 18 wherein one of said tabsextends from a point on the exterior of said bulb portion closer to saidentry portion than the other of said tabs.